Prostatic urethral lift (UroLift): a real-world analysis of outcomes using hospital episodes statistics.
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ABSTRACT: Background
To determine real-world outcomes of prostatic urethral lift (UroLift) procedures conducted in hospitals across England.Methods
A retrospective observational cohort was identified from Hospital Episode Statistics data including men undergoing UroLift in hospitals in England between 2017 and 2020. Procedure uptake, patient demographics, inpatient complications, 30-day accident and emergency re-attendance rate, requirement for further treatment and catheterization were captured. Kaplan-Meier and hazard analysis were used to analyse time to re-treatment.Results
2942 index UroLift procedures from 80 hospital trusts were analysed; 85.3% conducted as day-case surgery (admitted to hospital for a planned surgical procedure and returning home on the same day). In-hospital complication rate was 3.4%. 93% of men were catheter-free at 30 days. The acute accident and emergency attendance rate within 30 days was 12.0%. Results of Kaplan Meier analysis for subsequent re-treatment (including additional UroLift and endoscopic intervention) at 1 and 2 years were 5.2% [95% CI 4.2 to 6.1] and 11.9% [10.1 to 13.6] respectively.Conclusions
This real-world analysis of UroLift shows that it can be delivered safely in a day-case setting with minimal morbidity. However, hospital resource usage for catheterization and emergency hospital attendance in the first 30 days was substantial, and 12% required re-treatment at 2 years.
SUBMITTER: Page T
PROVIDER: S-EPMC8028737 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:PurposeThis study aimed to assess the clinical outcomes of prostatic urethral lift in Korean patients with bothersome lower urinary tract symptoms due to benign prostatic hyperplasia (BPH).Materials and methodsThirty-two men with symptomatic BPH were consecutively treated in a tertiary care center in Korea. To be included in the present analysis, patients had to meet the following criteria: age ≥50 years, International Prostatic Symptom Score (IPSS) >12, and prostate volume between 30 mL and 80 mL. Patients were evaluated up to a median follow-up period of 1 year post-procedure. The primary outcomes included symptom relief, improvement of quality of life (QOL), and preservation of sexual function.ResultsAll procedures were finished with a mean of 2.2 implants without any serious complication. The numbers of patients diagnosed with diabetes mellitus, hypertension, and ischemic heart disease were 16 (50.0%), 24 (75.0%), and 9 (28.1%), respectively. Patients experienced symptom relief by 1 week that was sustained for 12 months. The mean IPSS, QOL, and maximum flow rate improved to 43%, 70%, and 25% by 1 week, and to 41%, 60%, and 32% by 12 months (p<0.001), respectively. There were no occurrences of early urge incontinence, retrograde ejaculation, or erectile dysfunction. Patient-reported adverse events were mild and transient.ConclusionsProstatic urethral lift is a safe and effective treatment for BPH in the Asian population. This treatment is minimally invasive, can be performed under local anesthesia, and may be an appropriate method for fragile patients.
| S-EPMC7308227 | biostudies-literature
Project description:Treatment options for patients with benign prostatic hyperplasia have traditionally revolved around pharmacotherapy or invasive surgery, both of which can negatively impact quality of life (QoL). The quest for a suitable minimally invasive surgical therapy as an alternative to long-term medication or conventional surgery, has seen the development of heat-based therapies, most of which have been dismissed because of post-operative complications and unacceptable re-treatment rates. During the late 1980s and 1990s, mechanical approaches such as transurethral balloon dilation and prostatic urethral stenting were investigated; however, re-treatment rates, encrustation and unacceptable migration rate of stents saw these options fall into disuse. In 2004, a new non-thermal, mechanical approach-the Prostatic Urethral Lift (PUL; UroLift®, NeoTract Inc., Pleasanton, CA, USA) was first investigated as a minimally invasive therapy for men with lower urinary tract symptoms (LUTS) secondary to BPH. A randomised "sham"-controlled clinical trial of PUL commenced enrolment in 2010. Results of 4-year follow-up have recently been published. This paper reviews these results, the latest literature on PUL and places them in perspective with regard to the proposed criteria for the optimal minimally invasive approach to treating LUTs in men with BPH.
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Project description:Evidence indicating Prostatic Urethral Lift (PUL) delivers significant improvement in symptomatic BPH with low morbidity is based on subjects with lateral lobe (LL) enlargement only. MedLift was an FDA IDE extension of the L.I.F.T. randomized study designed to examine safety and efficacy of PUL for treatment of obstructive middle lobes (OML). Inclusion criteria for this non-randomized cohort were identical to the L.I.F.T. randomized study, except for requiring an OML: ≥ 50 years of age, IPSS ≥ 13, and Qmax ≤ 12 ml/s. Primary endpoint analysis quantified improvement in IPSS over baseline and rate of post-procedure serious complications. Quantification of symptom relief, quality of life, flow rate, and sexual function occurred through 12 months. Outcomes were compared to historical L.I.F.T LL results and were combined to demonstrate the full effectiveness of PUL. Of the 71 screened subjects, 45 were enrolled. At 1, 3, 6, and 12 months, mean IPSS improved from baseline at least 13.5 points (p < 0.0001). Quality of life and BPHII were similarly improved (>60% and >70%, respectively at 3, 6, and 12 months, p < 0.0001). Mean Qmax improvement ranged from 90 to 129% (p < 0.0001). At 1 month, 86% (CI 73-94%) reported ≥70 on the Quality of Recovery scale, 80% (CI 66-89%) reported being "much" or "very much better," and 89% (CI 76-95%) would recommend the procedure. Compared to LL subjects, OML subjects' symptoms improved at least as much at every time point (OML range 13.5-15.9, LL range 9.9-11.1, p ≤ 0.01). On combining OML with LL data, >70% (range CI 63-81%) of subjects demonstrated ≥ 8 point improvement in IPSS through 12 months. Analysis of the combined dataset indicates ≥ 40% (CI 30-51%) of sexually active men improved the minimal clinically important difference in erectile function through 12 months. Prostates, including those with middle lobe obstruction, can be treated with the PUL procedure safely and effectively.
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Project description:ContextRecently, prostatic urethral lift (PUL) is being used to treat lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Although preliminary clinical studies on PUL are increasing, the long-term efficacy and safety of this procedure are still not well evaluated.ObjectiveThe objective of our study is to synthesize the existing literature evidence, and make a comprehensive and long-term systematic review for the PUL procedure.Evidence acquisitionA systematic search was performed from the electronic databases including PubMed, Embase, and OVID. The search period was up to January 1, 2020. Comprehensive retrospective and prospective studies on PUL were collected in accordance with specific inclusion and exclusion criteria. Pooled prostatic symptom scores, sexual health scores, and functional outcomes were calculated by using a fixed or random-effect model.Evidence synthesisNineteen articles meet our determined inclusion and exclusion criteria, and 11 independent patient series were included in the final analysis. Meta-analysis results indicated improvement after the PUL procedure, including International Prostate Symptom Score improvement of 9.73-12.16 points, BPH Impact Index improvement of 3.74-4.50 points, maximum flow rate improvement of 3.44-4.26 ml/s, and quality of life improvement of 2.20-2.55 points. Postvoid residual volume at most of the intervals was not significantly variable. Data regarding sexual function remained stable or improved slightly during the 24-mo follow-up period. Pooled estimates were largely heterogeneous except for sexual function.ConclusionsPUL can continue to relieve prostatic symptoms for 24 mo without causing serious complications. The extremely important advantage of the PUL procedure is that it can preserve or slightly improve sexual function. Longer-term and more comprehensive clinical trials are still needed to further clarify the functional outcomes and cost effectiveness of PUL.Patient summaryProstatic urethral lift is an attractive option for selected patients who seek rapid and durable relief of lower urinary tract symptoms with complete preservation of sexual function.
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